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Hand Rehab Using AMADEO in PD Patients (P-AMA)

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

AMADEO

Training

OT Training

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Idiopathic PD diagnosed according to the Gelb's criteria;
Hoehn-Yahr stage 1- 3
"On" state
MMSE score ≥ 24
Willing and able to give written informed consent;
Willing and able to comply with the study procedures.

Exclusion Criteria

A specific kind of fluctuation: Sudden on-off fluctuations
History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
History of stereotaxic brain surgery for PD;
Mini-mental examination (MMSE) score less than 24 at screening;
Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
Presence of severe dyskinesia prior to baseline;
Any other medical or psychiatric condition that may compromise the patient's participation in this study;

Sites / Locations

IRCCS Centro Neurolesi "Bonino-Pulejo"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AMADEO Training

OT training

Arm Description

Twenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality.

Twenty control subjects (PD patients) will be treated with traditional rehabilitation focused on fine hand-finger movement skills. The patients in this group will undergo the same amount of treatment. Both the groups will be trained with conventional physiotherapy concerning postural, balance and gait.

Outcomes

Primary Outcome Measures

Nine hole peg test

9HPT is used to measure finger dexterity in patients with various neurological diagnoses

Secondary Outcome Measures

Bipolar surface electromyography

EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.

Full Information

NCT ID

NCT04045080

First Posted

August 2, 2019

Last Updated

February 19, 2020

Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo"

1. Study Identification

Unique Protocol Identification Number

NCT04045080

Brief Title

Hand Rehab Using AMADEO in PD Patients

Acronym

P-AMA

Official Title

The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AMADEO Training

Arm Type

Experimental

Arm Description

Arm Title

OT training

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

AMADEO

Intervention Description

AMADEO® is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers. Moreover, even without muscular strength, active work can be done using EMG-based training. The Continuous Passive Motion (CPM Plus) therapy facilitates the implementation of automatic movement sequences even when the patient is unable to complete the entire range of motion on their own. It may be used in all phases of finger-hand rehabilitation and can be adapted to the needs of every patient. In patients with PD, it will be useful in improving bradykinesia and potentially distal hypostenia.

Intervention Type

Other

Intervention Name(s)

Training

Intervention Description

training

Intervention Type

Other

Intervention Name(s)

OT Training

Intervention Description

training

Primary Outcome Measure Information:

Title

Nine hole peg test

Description

9HPT is used to measure finger dexterity in patients with various neurological diagnoses

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Bipolar surface electromyography

Description

EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Idiopathic PD diagnosed according to the Gelb's criteria; Hoehn-Yahr stage 1- 3 "On" state MMSE score ≥ 24 Willing and able to give written informed consent; Willing and able to comply with the study procedures. Exclusion Criteria A specific kind of fluctuation: Sudden on-off fluctuations History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms; History of stereotaxic brain surgery for PD; Mini-mental examination (MMSE) score less than 24 at screening; Changes in Levodopa (DA) dose in any time within 4 week prior to baseline; Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline; Presence of severe dyskinesia prior to baseline; Any other medical or psychiatric condition that may compromise the patient's participation in this study;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rocco S Calabrò

Phone

+3909060128166

salbro77@tiscali.it

First Name & Middle Initial & Last Name or Official Title & Degree

Rossella Ciurleo

Phone

+3909060128109

rosella.ciurleo@irccsme.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rocco S Calabrò

Organizational Affiliation

IRCCS Centro Neurolesi

Official's Role

Study Chair

Facility Information:

Facility Name

IRCCS Centro Neurolesi "Bonino-Pulejo"

City

Messina

ZIP/Postal Code

98124

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rossella Ciurleo

rossella.ciurleo@irccsme.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Hand Rehab Using AMADEO in PD Patients

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